SENSITESTER— 510(k) K871167

Substantially Equivalent

Dexin Pty. , Ltd.

FDA 510(k) clearance K871167 for SENSITESTER, Substantially Equivalent on 1987-04-01. Applicant: Dexin Pty. , Ltd.. Device class: 1.

Clearance details

Applicant: Dexin Pty. , Ltd.
Product code: Code GWY
Device class: Class 1
Regulation: 21 CFR 882.1750
Advisory panel: Neurology
Date received: 1987-03-24
Decision date: 1987-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Western Australia, AU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.